EASD: Byetta Wins In Head to Head Trial Over Januvia In Postprandial Glucose

In a month-long head-to-head trial, the incretin mimetic exenatide (Byetta) reduced postprandial glucose in type 2 diabetes more than did sitagliptin (Januvia), an oral DPP-4 inhibitor, researchers reported. The results of the double-blind crossover study suggested that direct reproduction of GLP-1 with exenatide was more effective than indirect enhancement of GLP-1 via DPP-4 inhibition, said Ralph DeFronzo, M.D., of the University of Texas Health Science Center San Antonio. Dr. DeFronzo was a co-author of the study and chair of the European Association for the Study of Diabetes poster session where the results were reported.

GLP-1-based therapies reproduce or enhance the actions of the naturally occurring peptide, GLP-1, and control glucose without causing weight gain. Sitagliptin is a DPP-4 inhibitor.

The finding was based on an intention-to-treat analysis in 95 patients ages 18 to 70. All patients were on a stable metformin treatment regimen and all had baseline hemoglobin A1c from 7% to 11% and fasting plasma glucose of less than 15.5 mmol/L.

But other researchers criticized the endpoint of the trial, postprandial glucose, and the trial’s duration — two weeks before crossing patients over to a different treatment.

Tina Vilsbøll, M.D., of Gentofte Hospital at the University of Copenhagen, stated that, while the trial was interesting, it was "not a true head-to-head comparison because for that you need a trial to last at least 12 weeks and you need a clinically meaningful endpoint — hemoglobin A1c."

She added that it was well known that two-hour postprandial glucose does not decrease with sitagliptin treatment. Moreover, 34% of exenatide patients versus 12% of sitagliptin patients experienced nausea and 25% of the exenatide patients reported vomiting versus 3% of the sitagliptin patients. "So you have nausea, vomiting, and injections to consider," Dr. Vilsbøll said.